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Comparison · NCT02545907-de66b39b

Dose Level 0- Safety Population vs Dose Level 1- Safety Population: Number of Participants Experiencing Grade 3 or 4 Toxicity as Assessed by CTCAE v4.0.

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Dose Level 0- Safety Population vs Dose Level 1- Safety Population: Number of Participants Experiencing Grade 3 or 4 Toxicity as Assessed by CTCAE v4.0. Trial comparisons, record NCT02545907-de66b39b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02545907-de66b39b

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.6670.2080.939wilson
Risk in group 20.4290.1580.75wilson
Risk difference, group 1 minus group 20.238-0.3220.621newcombe hybrid score
Risk ratio, group 1 over group 21.560.4825.02log
Odds ratio, group 1 over group 22.670.15845.1log
Number needed to treat, for one more participant with the outcome on Dose Level 0- Safety Population than on Dose Level 1- Safety Population4.2from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Dose Level 0- Safety PopulationAll patients allocated to dose level 0 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.23OG000
Group 2Dose Level 1- Safety PopulationAll patients allocated to dose level 1 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.37OG001

Outcome

Type
PRIMARY
Title
Number of Participants Experiencing Grade 3 or 4 Toxicity as Assessed by CTCAE v4.0.
Description
The percentage of patients treated who experience any grade 3 or 4 toxicity as assessed by CTCAE v4.0 throughout all treatment cycles will be assessed based on reported data.
Time frame
Between informed consent provided and 30 days post last trial treatment administration, up to 7 months
Population
All patients that receive at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.

Source ClinicalTrials.gov

Trial

Title
A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis
NCT number
NCT02545907
Phases
PHASE1, PHASE2
Conditions
Amyloidosis
Interventions
Carfilzomib, Thalidomide, Dexamethasone
Lead sponsor
University College, London
Results first posted
2021-04-15

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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